Oct 6 2010
CoreLab Partners, Inc, the global entity resulting from the merger between RadPharm and Medifacts International in February of this year, has recently completed the first ever regulatory mandated Thorough QT (TQT) study conducted in the Asia Pacific Rim and the first TQT study for a Japanese new drug application (NDA).
"We are pleased to announce that we have recently completed the first TQT study contracted in Japan processing over 20,000 ECGs in 260 patients for the duration of the study," said CoreLab Partners' President and Chief Executive Officer, Mike Woehler. "As the new E-14 Guidance formally takes effect on November 1, 2010, in Japan, we are seeing an increased demand for our consultative input as Japanese Pharmaceutical companies seek to gain our experience and expertise in the cardiac safety market sector to address this important regulatory mandate going forward," added Woehler. Through alliance partner, Suzuken Co, Ltd, CoreLab Partners provides local contact in the Asia Pacific Rim offering a comprehensive suite of cardiac safety solutions to address the growing cardiac safety activity in Japan. "This alliance supports both Japanese domestic and foreign Pharma sponsors in meeting the new regulatory requirements for cardiac safety and drug approval in Japan," said Suzuken's Director, Senior Executive Officer, Nobuo Suzuki.